e-Therapeutics plc has announced interim results from its phase Ia UK study evaluating the safety, dosing and anti-tumour activity of ETS2101 (dexanabinol) in patients with advanced solid tumours.
Following the completion of six dose escalation steps up to 22mg/kg, ETS2101 was found to be well tolerated at all doses by all patients with no serious adverse events attributed to the drug reported. In an earlier cohort, a single incident of dose-limiting fatigue was noted, but has not been repeated in any other patient to date.
In addition, analysis of data from the trial indicates that tumour development might be being retarded by the activity of ETS2101 in patients who joined the trial with progressive disease with a wide variety of tumour types.
The UK Clinical Investigators therefore intend to continue to enrol further patients at higher dose levels, and to continue to escalate until a maximum tolerated dose has been established. The observation that progression of the tumour might be affected by higher doses of ETS2101 is clearly one that the UK Principal Clinical Investigator is keen to explore further.
Professor Ruth Plummer, trial Principal Investigator at the Bobby Robson Cancer Centre at the Freeman Hospital in Newcastle upon Tyne said: “In the last two cohorts (15mg/kg and 22mg/kg), we have seen a number of patients who have come onto the study with advanced progressive disease and have stayed on study in some cases for over five months. This suggests that the compound may be halting tumour progression as measured by RECIST criteria. We are excited by this initial observation, and are very keen to continue to escalate the dose to confirm this and explore if further possible anti-tumour effects will be found.”
e-Therapeutics’ Development Director, Steve Self, said: “The latest findings from ETS2101 are encouraging. We will continue to dose escalate to find the maximum tolerated dose and further explore the observations of possible activity in cancer patients that we have seen in the most recent two cohorts. These data, along with the US phase I data, are important in helping us to refine the next steps with this compound. We very much appreciate the contribution of Professor Plummer and all our investigators and their patients to this study, and are looking forward to further findings from the trial as it extends to higher doses.”